Various cardiovascular procedures, such as angioplasty and stent placement among others, are performed by inserting into and manipulating within a patient's vasculature, wires and catheters adapted to perform those procedures. In coronary and other such vascular interventional procedures access to the vasculature typically is percutaneous, often through the femoral artery, involving insertion of a needle in the region of the groin to form a track through subcutaneous tissue and to puncture and create an arteriotomy in the artery. A short guidewire then is advanced through the needle and into the femoral artery. The needle then is removed and a dilator carrying an introducer sheath then is advanced over the guidewire, along the needle track and into the femoral artery. The dilator enlarges the track through the tissue and widens the puncture in the vessel so that it may receive subsequent guidewires, catheters and the like. With the introducer sheath having been advanced into the vessel, the dilator and short guidewire are removed leaving the sheath in place. The sheath provides access into the femoral artery, through the arteriotomy, for catheters or other instrumentalities in order to perform the selected procedure.
After the procedure has been completed, the procedural devices are removed and the arteriotomy must be closed. A number of techniques are known to facilitate closure and healing of the arteriotomy. These include application of pressure at the puncture site for a relatively extended length of time, or the use of biological adhesives or plugs adapted to seal the arteriotomy, or the use of staples or clips. Some closure systems include an arrangement to engage the artery to temporarily draw the edges of the arteriotomy together while a final closure device, such as a stapler, sutures, adhesives or other means is used to effect the permanent closure of the arteriotomy. Some of these systems result in piercing the vessel wall or other tissue, such as systems described, for example, in U.S. Pat. No. 6,767,356 (Kanner) and U.S. Pat. No. 6,391,048 (Ginn et al.).
It would be desirable to provide an alternate system for effecting hemostasis of a vascular puncture wound without risking the trauma that may result from piercing the vascular wall and also to avoid the risk of a closure element projecting into the interior of the vessel lumen. The present invention is directed to such an alternative device and technique.